Syringe-based fluid diversion mechanism for bodily fluid sampling

ABSTRACT

A syringe-based device includes a housing, a pre-sample reservoir, and an actuator. The housing defines an inner volume between a substantially open proximal end portion and a distal end portion that includes a port couplable to a lumen-defining device. The pre-sample reservoir is fluidically couplable to the port to receive and isolate a first volume of bodily fluid. The actuator is at least partially disposed in the inner volume and has a proximal end portion that includes an engagement portion and a distal end portion that includes a sealing member. The engagement portion is configured to allow a user to selectively move the actuator between a first configuration such that bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration such that bodily fluid can flow from the port to a sample reservoir defined at least in part by the sealing member and the housing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. ProvisionalPatent Application Ser. No. 61/731,620, entitled “Syringe Based FluidDiversion Mechanism For Bodily-Fluid Sampling,” filed Nov. 30, 2012, thedisclosure of which is incorporated herein by reference in its entirety.

BACKGROUND

Embodiments described herein relate generally to the parenteralprocurement of bodily-fluid samples, and more particularly to devicesand methods for parenterally-procuring bodily-fluid samples with reducedcontamination from microbes or other contaminants exterior to thebodily-fluid source, such as dermally-residing microbes.

Health care practitioners routinely perform various types of microbialtests on patients using parenterally-obtained bodily-fluids. In someinstances, patient samples (e.g., bodily-fluids) are tested for thepresence of one or more potentially undesirable microbes, such asbacteria, fungi, or yeast (e.g., Candida). Microbial testing may includeincubating patient samples in one or more sterile vessels containingculture media that is conducive to microbial growth, real-timediagnostics, and/or PCR-based approaches. Generally, when such microbesare present in the patient sample, the microbes flourish over time inthe culture medium. After a pre-determined amount of time (e.g., a fewhours to several days), the culture medium can be tested for thepresence of the microbes. The presence of microbes in the culture mediumsuggests the presence of the same microbes in the patient sample which,in turn, suggests the presence of the same microbes in the bodily-fluidof the patient from which the sample was obtained. Accordingly, whenmicrobes are determined to be present in the culture medium, the patientmay be prescribed one or more antibiotics or other treatmentsspecifically designed to treat or otherwise remove the undesiredmicrobes from the patient.

Patient samples, however, can become contaminated during procurement.One way in which contamination of a patient sample may occur is by thetransfer of microbes from a bodily surface (e.g., dermally-residingmicrobes) dislodged during needle insertion into a patient andsubsequently transferred to a culture medium with the patient sample.The bodily surface and/or other undesirable external microbes may bedislodged either directly or via dislodged tissue fragments, hairfollicles, sweat glands and other adnexal structures. Another possiblesource of contamination is from the person drawing the patient sample.For example, a doctor, phlebotomist, nurse, etc. can transfercontaminants from their body (e.g., finger, arms, etc.) to the patientsample. The transferred microbes may thrive in the culture medium andeventually yield a positive microbial test result, thereby falselyindicating the presence of such microbes in vivo. Such inaccurateresults are a concern when attempting to diagnose or treat a suspectedillness or condition. For example, false positive results from microbialtests may result in the patient being unnecessarily subjected to one ormore anti-microbial therapies, which may cause serious side effects tothe patient including, for example, death, as well as produce anunnecessary burden and expense to the health care system.

As such, a need exists for improved bodily-fluid transfer devices andmethods that reduce microbial contamination in bodily-fluid testsamples.

SUMMARY

Devices for parenterally-procuring bodily-fluid samples with reducedcontamination from microbes exterior to the bodily-fluid source, such asdermally-residing microbes, are described herein. In some embodiments, asyringe-based device for parenterally-procuring bodily fluid sampleswith reduced contamination from a patient includes a housing, apre-sample reservoir, and an actuator mechanism. The housing has aproximal end portion and a distal end portion and defines an innervolume therebetween. The proximal end portion is substantially open andthe distal end portion has a port configured to be coupled to alumen-defining device for receiving bodily fluids from the patient. Thepre-sample reservoir is fluidically couplable to the port and isconfigured to receive and isolate a first volume of bodily fluidwithdrawn from the patient. The actuator mechanism is at least partiallydisposed in the inner volume of the housing and has a proximal endportion and a distal end portion. The distal end portion includes asealing member and the proximal end portion includes an engagementportion configured to allow a user to selectively move the actuatormechanism between a first configuration in which the bodily fluid canflow from the port to the pre-sample reservoir, and a secondconfiguration in which the bodily fluid can flow from the port to asample reservoir defined at least in part by the sealing member and thehousing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a syringe-based transfer deviceaccording to an embodiment.

FIG. 2 is a front view of a syringe-based transfer device according toan embodiment, in a first configuration.

FIG. 3 is an exploded view of the syringe-based transfer device of FIG.2.

FIG. 4 is a cross-sectional view of the syringe-based transfer deviceillustrated in FIG. 2 taken along the line X₁-X₁, in the firstconfiguration.

FIG. 5 is a cross-sectional view of the syringe-based transfer device ofFIG. 2 taken along the line X₁-X₁, in a second configuration.

FIG. 6 is a cross-sectional view of the syringe-based transfer device ofFIG. 2 taken along the line X₁-X₁, in a third configuration.

FIG. 7 is a front view of a syringe-based transfer device according toan embodiment, in a first configuration.

FIG. 8 is an exploded view of the syringe-based transfer device of FIG.7.

FIG. 9 is a cross-sectional view of the syringe-based transfer device ofFIG. 7 taken along the line X₂X₂, in the first configuration.

FIG. 10 is a cross-sectional view of the syringe-based transfer deviceof FIG. 7 taken along the line X₂-X₂, in a second configuration.

FIG. 11 is a front view of a syringe-based transfer device according toan embodiment, in a first configuration.

FIG. 12 is an exploded view of the syringe-based transfer device of FIG.11.

FIG. 13 is a cross-sectional view of the syringe-based transfer deviceof FIG. 11 taken along the line X₃-X₃, in the first configuration.

FIG. 14 is a cross-sectional view of the syringe-based transfer deviceof FIG. 11 taken along the line X₃-X₃, in a second configuration.

FIG. 15 is a cross-sectional view of the syringe-based transfer deviceof FIG. 11 taken along the line X₃-X₃, in a third configuration.

FIG. 16 is a flowchart illustrating a method of using a syringe-basedtransfer device to obtain a bodily fluid sample from a patient.

DETAILED DESCRIPTION

Devices for parenterally-procuring bodily-fluid samples with reducedcontamination from microbes exterior to the bodily-fluid source, such asdermally-residing microbes, are described herein. In some embodiments, asyringe-based device for parenterally-procuring bodily fluid sampleswith reduced contamination from a patient includes a housing, apre-sample reservoir, and an actuator mechanism. The housing has aproximal end portion and a distal end portion and defines an innervolume therebetween. The proximal end portion is substantially open andthe distal end portion has a port configured to be coupled to alumen-defining device for receiving bodily fluids from the patient. Thepre-sample reservoir is fluidically couplable to the port and isconfigured to receive and isolate a first volume of bodily fluidwithdrawn from the patient. The actuator mechanism is at least partiallydisposed in the inner volume of the housing and has a proximal endportion and a distal end portion. The distal end portion includes asealing member and the proximal end portion includes an engagementportion configured to allow a user to selectively move the actuatormechanism between a first configuration in which the bodily fluid canflow from the port to the pre-sample reservoir, and a secondconfiguration in which the bodily fluid can flow from the port to asample reservoir defined at least in part by the sealing member and thehousing.

In some embodiments, a syringe-based device for parenterally-procuringbodily fluid samples with reduced contamination from a patient includesa housing and an actuator mechanism. The housing has a proximal endportion and a distal end portion and defines an inner volumetherebetween. The proximal end portion is substantially open and thedistal end portion has a port configured to be coupled to alumen-defining device for receiving bodily fluids from the patient. Theactuator mechanism is movably disposed in the inner volume. The actuatormechanism includes a first member having a proximal end portion and adistal end portion and defining an inner volume therebetween, and asecond member movably disposed in the inner volume of the first member.The distal end portion of the first member includes a first plungerincluding a flow channel configured to allow selective fluidcommunication between the inner volume defined by the housing and theinner volume defined by the first member. The second member includes asecond plunger disposed at a distal end portion of the second member andan engagement portion configured to allow a user to selectively move theactuator mechanism.

In some embodiments, a syringe-based device for parenterally-procuringbodily fluid samples with reduced contamination from a patient includesa housing, an actuator mechanism, and a piercing member. The housing hasa proximal end portion and a distal end portion and defines an innervolume therebetween. The proximal end portion is substantially open andthe distal end portion has a port configured to be coupled to alumen-defining device for receiving bodily fluids from the patient. Theactuator mechanism is movably disposed in the inner volume of thehousing. The actuator mechanism has a proximal end portion and a distalend portion and defining an inner volume therebetween. The distal endportion includes a plunger including a flow channel. The proximal endportion is substantially open and configured to receive a vacuum-sealedsample tube. The piercing member is disposed in the inner volume of theactuator mechanism and defines a lumen fluidically coupled to the flowchannel of the plunger. The flow channel of the plunger and the piercingmember configured to allow selective fluid communication between theinner volume defined by the housing and the inner volume defined by theactuator mechanism.

In some embodiments, a syringe-based device for parenterally-procuringbodily fluid samples with reduced contamination from a patient includesa housing, an actuator mechanism, and a flow control mechanism. Thehousing has a proximal end portion and a distal end portion and definesan inner volume therebetween. The proximal end portion is substantiallyopen and the distal end portion has a port configured to be coupled to alumen-defining device for receiving bodily fluids from the patient. Theactuator mechanism is movably disposed in the inner volume of thehousing and has a proximal end portion and a distal end portion. Thedistal end portion includes a first plunger and the proximal end portionincluding an engagement portion configured to allow a user toselectively move the actuator mechanism. A second plunger is movablydisposed in the inner volume of the housing and releasably coupled tothe actuator mechanism. The second plunger defines a flow channelconfigured to be placed in selective fluid communication with the port.The flow control mechanism is operable to selectively control fluid flowbetween the port and a pre-sample reservoir defined by the secondplunger and the housing. The flow control mechanism is configured to bemoved between a first configuration in which the bodily fluid can flowthrough a first flow path to the pre-sample reservoir, and a secondconfiguration in which the bodily fluid can flow through a second flowpath to a sample reservoir collectively defined by the first plunger,the second plunger, and the housing.

In some embodiments, a method of using a syringe-based transfer device,including a housing with a port and an actuator mechanism movablydisposed in the housing, to obtain a bodily fluid sample from a patientincludes establishing fluid communication between the patient and theport of the syringe-based transfer device and establishing fluidcommunication between the port and a pre-sample reservoir. A firstvolume of bodily fluid is transferred to the pre-sample reservoir withthe syringe-based transfer device. The pre-sample reservoir isfluidically isolated from the port to sequester the first volume ofbodily fluid in the pre-sample reservoir. After the first volume ofbodily fluid has been sequestered in the pre-sample reservoir, fluidcommunication is established between the port and a sample reservoirdefined at least in part by the actuator mechanism and the housing. Theactuator mechanism is moved from a first position to a second positionto draw a second volume of bodily fluid from the patient into the samplereservoir.

In some embodiments, an apparatus includes a housing and an actuatormechanism. The apparatus further includes a first fluid reservoir and asecond fluid reservoir, fluidically isolated from the first fluidreservoir, defined at least in part by the housing and/or the actuatormechanism. The housing includes a port configured to receive abodily-fluid. The housing and the actuator mechanism collectively definea first fluid flow path and a second fluid flow path. The first fluidflow path is configured to transfer a first flow of bodily-fluid fromthe port to the first fluid reservoir when the actuator mechanism is ina first position relative to the housing. The second fluid flow path isconfigured to transfer a second flow of bodily-fluid, substantially freefrom undesirable microbes that are not representative of in vivo patientcondition, from the port to the second fluid reservoir when the actuatormechanism is in a second position relative to the housing.

In some embodiments, a bodily-fluid transfer device can be configured toselectively divert a first, predetermined amount of a flow of abodily-fluid to a first reservoir before permitting the flow of a secondamount of the bodily-fluid into a second reservoir. In this manner, thesecond amount of bodily-fluid can be used for diagnostic or othertesting, while the first amount of bodily-fluid, which may containmicrobes from a bodily surface and/or other external source, is isolatedfrom the bodily-fluid to be tested for microbial presence but yet can beused for other blood tests as ordered by clinician (e.g., complete bloodcount “CBC”, immunodiagnostic tests, cancer-cell detection tests, or thelike).

As referred to herein, “bodily-fluid” can include any fluid obtainedfrom a body of a patient, including, but not limited to, blood,cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serousfluid, pleural fluid, amniotic fluid, and the like, or any combinationthereof.

As used herein, the term “set” can refer to multiple features or asingular feature with multiple parts. For example, when referring to setof walls, the set of walls can be considered as one wall with distinctportions, or the set of walls can be considered as multiple walls.Similarly stated, a monolithically constructed item can include a set ofwalls. Such a set of walls can include, for example, multiple portionsthat are in discontinuous from each other. A set of walls can also befabricated from multiple items that are produced separately and arelater joined together (e.g., via a weld, an adhesive or any suitablemethod).

As used in this specification, the words “proximal” and “distal” referto the direction closer to and away from, respectively, a user who wouldplace the device into contact with a patient. Thus, for example, the endof a device first touching the body of the patient would be the distalend, while the opposite end of the device (e.g., the end of the devicebeing manipulated by the user) would be the proximal end of the device.

As used in this specification and the appended claims, the terms “first,predetermined amount,” “first amount,” and “first volume” describe anamount of bodily-fluid configured to be received or contained by a firstreservoir or a pre-sample reservoir. While the terms “first amount” and“first volume” do not explicitly describe a predetermined amount, itshould be understood that the first amount is the first, predeterminedamount unless explicitly described differently.

As used in this specification and the appended claims, the terms “secondamount” and “second volume” describe an amount of bodily-fluidconfigured to be received or contained by a second reservoir or samplereservoir. The second amount can be any suitable amount of bodily-fluidand need not be predetermined. Conversely, when explicitly described assuch, the second amount received and contained by the second reservoiror sample reservoir can be a second, predetermined amount.

FIG. 1 is a schematic illustration of a portion of a syringe-basedtransfer device 100, according to an embodiment. Generally, thesyringe-based transfer device 100 (also referred to herein as“bodily-fluid transfer device,” “fluid transfer device,” or “transferdevice”) is configured to permit the withdrawal of bodily-fluid from apatient such that a first portion or amount of the withdrawn fluid isfluidically isolated and diverted away from a second portion or amountof the withdrawn fluid that is to be used as a biological sample, suchas for testing for the purpose of medical diagnosis and/or treatment. Inother words, the transfer device 100 is configured to transfer a first,predetermined amount of a bodily-fluid to a first collection reservoirand a second amount of bodily-fluid to one or more bodily-fluidcollection reservoirs (e.g., sample reservoirs) fluidically isolatedfrom the first collection reservoir, as described in more detail herein.

The transfer device 100 includes a housing 101, an actuator mechanism140, a first fluid reservoir 180 (also referred to herein as “firstreservoir” or “pre-sample reservoir”), and a second fluid reservoir 190(also referred to herein as “second reservoir” or “sample reservoir”),different from the first reservoir 180. The housing 101 can be anysuitable shape, size, or configuration and is described in furtherdetail herein with respect to specific embodiments. As shown in FIG. 1,the housing 101 includes a port 105 that can be at least temporarilyphysically and fluidically coupled to a medical device defining apathway P for withdrawing and/or conveying the bodily-fluid from thepatient to the transfer device 100. For example, the port 105 can be aLuer-Lok® or the like configured to be physically and fluidicallycoupled to a needle, a cannula, or other lumen-containing device. Inother embodiments, the port 105 can be monolithically formed with atleast a portion of the lumen-containing device. In this manner, the port105 can receive the bodily-fluid from the patient via the pathway P asfurther described herein.

As shown in FIG. 1, the housing 101 defines an inner volume 111 that isconfigured to receive a portion of the actuator mechanism 140. Morespecifically, the actuator mechanism 140 is at least partially disposedwithin the inner volume 111 of the housing 101 and is movable between afirst configuration and a second configuration relative to the housing101. The housing 101 is also configured to house at least a portion ofthe first reservoir 180 and at least a portion of the second reservoir190. For example, in some embodiments, the first reservoir 180 and/orthe second reservoir 190 can be at least temporarily disposed within theinner volume 111 defined by the housing 101. In other embodiments, thefirst reservoir 180 and/or the second reservoir 190 can be at leastpartially defined by a set of walls of the housing 101 that define theinner volume 111. Similarly stated, a portion of the inner volume 111can form at least a portion of the first reservoir 180 and/or a portionof the second reservoir 190.

The actuator mechanism 140 can be any suitable shape, size, orconfiguration. For example, in some embodiments, the shape and size ofat least a portion of the actuator mechanism 140 substantiallycorresponds to the shape and size of the walls of the housing 101defining the inner volume 111. As described above, at least a portion ofthe actuator mechanism 140 is movably disposed within the inner volume111 of the housing 101. For example, in some embodiments, a distal endportion of the actuator mechanism 140 is disposed within the innervolume 111 of the housing 101 and a proximal end portion of the actuatormechanism 140 is disposed substantially outside the housing 101. In thismanner, a user can engage the proximal end portion of the actuatormechanism 140 to move the portion of the actuator mechanism 140 disposedwithin the inner volume 111 between the first configuration and thesecond configuration relative to the housing 101. In some embodiments,the actuator mechanism 140 can be disposed in a third configuration (orstorage configuration) relative to the housing 101, as further describedherein.

While not shown in FIG. 1, in some embodiments, the actuator mechanism140 can include a first member and a second member. In such embodiments,both the first member and the second member can be collectively movedwithin the inner volume 111 of the housing 101. In addition, the firstmember and the second member can be configured to move independentlywithin the housing 101. Similarly stated, the first member can be movedrelative to the second member and/or the second member can be movedrelative the first member, as further described below with respect tospecific embodiments. In some embodiments, the first member and/or thesecond member can form a piston or plunger configured to move within theinner volume 111. Furthermore, a portion of the piston or plunger canform a substantially fluid tight seal with the walls of the housing 101defining the inner volume 111. In this manner, the housing 101 and theactuator mechanism 140 can collectively form a sealed, air-tight cavity(e.g., a syringe) such that the actuator mechanism 140 (or at least aportion of the actuator mechanism 140) can be configured to introduce orotherwise facilitate the development of a vacuum within the inner volume111.

The first reservoir 180 can be any suitable reservoir for containing thebodily-fluid. For example, in some embodiments, the first reservoir 180is defined by a portion of the walls of the housing 101 defining theinner volume 111 and a portion of the actuator mechanism 140. In otherembodiments, the first reservoir 180 is defined by only the actuatormechanism 140. In still other embodiments, the first reservoir 180 canbe a pre-sample reservoir described in detail in U.S. Pat. No. 8,197,420(“the '420 patent”), the disclosure of which is incorporated herein byreference in its entirety. In this manner, the first reservoir 180 canbe selectively placed in fluid communication with the housing 101 or theactuator mechanism 140 either directly (e.g., physically and fluidicallycoupled to the housing 101 or the actuator mechanism 140) or indirectly(e.g., fluidically coupled via intervening structure such as sterileflexible tubing).

The first reservoir 180 is configured to receive and contain the first,predetermined amount of the bodily-fluid. More specifically, when theactuator mechanism 140 is in the first configuration, a portion of theactuator mechanism 140 and a portion of the housing 101 can define afirst fluid flow path 181 configured to fluidically couple the port 105of the housing 101 to the first reservoir 180. In some embodiments, theactuator mechanism 140 can be moved to the first configuration (e.g.,from the third configuration described above) and can introduce a vacuumthat facilitates the flow of the bodily-fluid through the first flowpath 181 and into the first reservoir 180. The first reservoir 180 isconfigured to contain the first amount of the bodily-fluid such that thefirst amount is fluidically isolated from a second amount of thebodily-fluid (different than the first amount of bodily-fluid) that issubsequently withdrawn from the patient.

The second reservoir 190 can be any suitable reservoir and is configuredto receive and contain the second amount of the bodily-fluid. In someembodiments, the second reservoir 190 is defined by a portion of thewalls of the housing 101 defining the inner volume 111 and a portion ofthe actuator member 140. In this manner, when the actuator mechanism 140is in the second configuration, a portion of the actuator mechanism 140and a portion of the housing 101 can define a second fluid flow path 191configured to fluidically couple the port 105 to the second reservoir190. In some embodiments, the movement of the actuator mechanism 140 tothe second configuration can be such that a second vacuum forcefacilitates the flow of the bodily-fluid through the second flow path191 and into the second reservoir 190. The second amount of bodily-fluidcan be an amount withdrawn from the patient subsequent to withdrawal ofthe first amount. In some embodiments, the second reservoir 190 isconfigured to contain the second amount of the bodily-fluid such thatthe second amount is fluidically isolated from the first amount of thebodily-fluid.

As described above, the transfer device 100 can be used to transfer abodily-fluid from a patient to the first reservoir 180 and/or secondreservoir 190 included in the transfer device 100. More specifically,the flow of the first amount of bodily-fluid transferred to the firstreservoir 180 can be such that dermally-residing microbes dislodgedduring a venipuncture event and/or other external sources (e.g. ambientairborne microbes, transferred from the skin of the practitionercollecting the sample, etc.) become entrained in the flow and arethereby transferred to the first reservoir 180. In addition, the firstreservoir 180 fluidically isolates the first amount such that when thesubsequent second amount is withdrawn into the second reservoir 190, thesecond amount is substantially free from the dermally-residing microbes.Although not shown in FIG. 1, in some embodiments, the syringe-basedtransfer device 100 can be coupled to a device in fluid communicationwith the patient that is also configured to reduce contamination of apatient sample. For example, in some embodiments, the syringe-basedtransfer device 100 can be used with a lumenless needle or the like suchas those described in U.S. Patent Application Ser. No. 61/777,758,entitled “Lumenless Needle for Bodily-Fluid Sample Collection,” filed onMar. 12, 2013 (“the '758 application”) the disclosure of which isincorporated herein by reference in its entirety.

In some embodiments, the transfer device 100 can be configured such thatthe first amount of bodily-fluid need be conveyed to the first reservoir180 before the transfer device 100 will permit the flow of the secondamount of bodily-fluid to be conveyed through the second flow path 191to the second reservoir 180. In this manner, the transfer device 100 canbe characterized as requiring compliance by a health care practitionerregarding the collection of the first, predetermined amount (e.g., apre-sample) prior to collection of the second amount (e.g., a sample) ofbodily-fluid. Similarly stated, the transfer device 100 can beconfigured to prevent a health care practitioner from collecting thesecond amount, or the sample, of bodily-fluid into the second reservoir190 without first diverting the first amount, or pre-sample, ofbodily-fluid into the first reservoir 180. In this manner, the healthcare practitioner is prevented from including (whether intentionally orunintentionally) the first amount of bodily-fluid, which is more likelyto contain dermally-residing microbes and/or other external undesirablecontaminants, in the bodily-fluid sample to be used for analysis. Inother embodiments, the fluid transfer device 100 need not include aforced-compliance feature or component.

In some embodiments, the actuator mechanism 140 can have a fourthconfiguration, different than the first, second, and thirdconfigurations. In such embodiments, the actuator mechanism 140 can bemoved towards the fourth configuration when the transfer device 100 hascollected the second amount of the bodily-fluid and has been removedfrom contact with the patient. When in the fourth configuration, thefirst fluid reservoir 180 can maintain the first amount of bodily-fluidin fluid isolation and the second fluid reservoir 190 can be maintainedin fluid communication with the port 105. Therefore, when the actuatormechanism 140 is moved toward the fourth configuration the transferdevice 100 can transfer a portion of the second amount of thebodily-fluid from the second reservoir 190 to any suitable container(e.g., a vile, a test tube, a petri dish, a culture medium, a testapparatus, or the like) such that the portion of the second amount ofbodily-fluid can be tested.

FIGS. 2-6 illustrate a syringe-based transfer device 200 according to anembodiment. The syringe-based transfer device 200 (also referred toherein as “bodily-fluid transfer device,” “fluid transfer device,” or“transfer device”) includes a housing 201 and an actuator mechanism 240.Furthermore, the transfer device 200 is configured to include or definea first fluid reservoir 280 (also referred to herein as “firstreservoir” or “pre-sample reservoir”) and a second fluid reservoir 290(also referred to herein as “second reservoir” or “sample reservoir”).The transfer device 200 can be any suitable shape, size, orconfiguration. For example, while shown in FIGS. 2 and 3 as beingsubstantially cylindrical, the transfer device 200 can be square,rectangular, polygonal, and/or any other non-cylindrical shape.

As shown in FIGS. 2 and 3, the housing 201 includes a proximal endportion 202 and a distal end portion 203 and defines an inner volume 211therebetween. In some embodiments, the housing 201 can be substantiallysimilar to a syringe body. The proximal end portion 202 of the housing201 is substantially open and is configured to receive at least aportion of the actuator mechanism 240 such that the portion of theactuator mechanism 240 is movably disposed within the inner volume 211.Furthermore, the inner volume 211 is configured to define the secondfluid reservoir 290, as further described herein. The distal end portion203 of the housing 201 includes a port 205. In some embodiments, theport 205 can be monolithically formed with the housing 201 (e.g., asshown in FIGS. 2-6). In other embodiments, the port 205 can be coupledto the distal end portion 203 in any suitable manner such as, forexample, via a friction fit, a threaded coupling, a mechanical fastener,an adhesive, any number of mating recesses, and/or any combinationthereof.

The port 205 can be any suitable shape, size, or configuration. Forexample, in some embodiments, at least a portion of the port 205 canform a lock mechanism configured to be physically and fluidicallycoupled to a needle, a cannula, or other lumen-containing device. Forexample, in some embodiments, the port 205 can be a Luer-Lok® or similarlocking mechanism configured to physically and fluidically couple to aneedle or cannula assembly (not shown in FIGS. 2-6). In otherembodiments, the port 205 can be monolithically formed with at least aportion of the lumen-containing device. In this manner, the port 205 canbe placed in fluid communication with a lumen defined by thelumen-defining device and to receive the bodily-fluid from a patientwhen the lumen-defining device is disposed within the patient (e.g., asa result of a venipuncture event), as further described herein.

As described above, the actuator mechanism 240 is disposed within theinner volume 211 and is movable between a first position (e.g., a distalposition relative to the housing 201) and a second position (e.g., aproximal position relative to the housing 201). Furthermore, themovement of the actuator mechanism 240 relative to the housing 201 canmove the transfer device 200 between a first, second, and thirdconfiguration, as further described herein. The actuator mechanism 240includes a first member 241 and a second member 251. The first member241 of the actuator mechanism 240 includes a proximal end portion 242and a distal end portion 243 and defines an inner volume 246therebetween. At least a portion of the inner volume 246 is configuredto define the first reservoir 280, as further described herein.

The proximal end portion 242 is substantially open such that at least aportion of the second member 251 can be movably disposed within theinner volume 246. The proximal end portion 242 also includes aprotrusion 244 that extends from an inner surface of a wall (or set ofwalls) defining the inner volume 246 and is configured to selectivelyengage a portion of the second member 251.

The distal end portion 243 of the first member 241 includes a plunger247. The plunger 247 is configured to form a friction fit with the innersurface of the walls defining the inner volume 211 when the actuatormechanism 240 is disposed within the housing 201. Similarly stated, theplunger 247 defines a fluidic seal with the inner surface of the wallsdefining the inner volume 211 such that a portion of the inner volume211 proximal of the plunger 247 is fluidically isolated from a portionof the inner volume 211 distal of the plunger 247. The plunger 247 isfurther configured to define a channel 248 that extends though a distalend and a proximal end of the plunger 247. Moreover, a portion of aninner set of walls defining the channel 248 is configured to form avalve seat 249. In this manner, a portion of the channel 248 can receivea valve 270 that is in contact with the valve seat 249.

The valve 270 can be any suitable valve. For example, in someembodiments, the valve 270 is a one-way check valve configured to allowa flow of a fluid from a distal end of the valve 270 to a proximal endof the valve 270 but substantially not allow a flow of the fluid fromthe proximal end to the distal end. In addition, the valve 270 can bedisposed within the channel 248 and can be in contact with the valveseat 249 such that the valve 270 forms a substantially fluid tight sealwith the walls defining the channel 248. In some embodiments, the valve270 can form a first fit with walls defining the channel 248. In otherembodiments, the valve 270 can form a threaded coupling or the like withat least a portion of the walls. The valve 270 can also include a sealmember configured to engage the valve seat 249 thereby forming at leasta portion of the fluid tight seal. The arrangement of the plunger 247and the valve 270 is such that when the valve 270 is in the openconfiguration, the inner volume 246 defined by the first member 241 isplaced in fluid communication with the portion of the inner volume 211of the housing 201 that is distal of the plunger 247, as furtherdescribed herein.

The second member 251 of the actuator mechanism 240 includes a proximalend portion 252 and a distal end portion 253. The proximal end portion252 includes an engagement portion 258 that can be engaged by a user(e.g., a phlebotomist, a nurse, a technician, a physician, etc.) to moveat least a portion of the actuator mechanism 240 relative to the housing201. The distal end portion 253 includes a plunger 257 configured toform a friction fit with the inner surface of the walls defining theinner volume 246 when the second member 251 is disposed with the firstmember 241. Similarly stated, the plunger 257 defines a fluidic sealwith the inner surface of the walls defining the inner volume 246 suchthat a portion of the inner volume 246 proximal of the plunger 257 isfluidically isolated from a portion of the inner volume 246 distal ofthe plunger 257.

As described above, at least a portion the second member 251 isconfigured to be movably disposed within the inner volume 246 of thefirst member 241. More specifically, the second member 251 can bemovable between a first position (e.g., a distal position) and a secondposition (e.g., a proximal position) thereby moving the actuatormechanism 240 between a first configuration and a second configuration,respectively. In addition, the second member 251 includes a protrusion254 that extends in a radial direction to selectively engage theprotrusion 244 of the first member 241. In this manner, the protrusion244 of the first member 241 and the protrusion 254 of the second member251 can be placed in contact to substantially limit a proximal movementof the second member 251 relative the first member 241.

In use, a user can engage the transfer device 200 to couple the port 205to a proximal end portion of a lumen-defining device (not shown) suchas, for example, a butterfly needle, a cannula assembly, a trocar (whichis some cases is used to insert a catheter into a patient), or the like.With the port 205 physically coupled to the lumen-defining device, theport 205 is placed in fluid communication with the lumen defined by thelumen-defining device. Furthermore, the distal end portion of thelumen-defining device can be disposed within a portion of the body of apatient (e.g., a vein). In this manner, the port 205 is placed in fluidcommunication with the portion of the body.

With the port 205 coupled to the lumen-defining device, a user (e.g., aphlebotomist, a nurse, a technician, a physician, or the like) can movethe transfer device 200 from the first configuration to the secondconfiguration. More specifically, the user can engage the engagementportion 258 of the second member 251 included in the actuator mechanism240 to move the actuator mechanism 240 from its first configuration toits second configuration, thereby placing the transfer device 200 in thesecond configuration, as indicated by the arrow AA in FIG. 5. In thismanner, the second member 251 of the actuator mechanism 240 is moved ina proximal direction relative to the first member 241 (e.g., the firstmember 241 does not substantially move in the proximal direction) untilthe protrusion 254 of the second member 251 is placed into contact withthe protrusion 244 of the first member 241.

The arrangement of the second member 251 within the first member 241 issuch that the proximal motion of the second member 251 increases thevolume of the portion of the inner volume 246 that is distal of theplunger 257, thereby defining the first reservoir 280. Furthermore, withthe plunger 257 forming a fluid tight seal with the inner surface of thewalls defining the inner volume 246, the increase of volume can producea negative pressure within the first reservoir 280.

As shown by the arrow BB in FIG. 5, the port 205, the valve 270, and thechannel 248 define a fluid flow path that places the first reservoir 280in fluid communication with the lumen-defining device. Therefore, thefirst reservoir 280 is placed in fluid communication with the portion ofthe patient (e.g., the vein). Expanding further, the negative pressurewithin the first reservoir 280 can be operative in moving the valve 270from a closed configuration to an open configuration. In this manner,the negative pressure within the within the first reservoir 280 producedby the movement of the plunger 257 introduces a suction force within theportion of the patient. Thus, a bodily-fluid is drawn through the port205 and the valve 270 and into the first reservoir 280. In someembodiments, the bodily-fluid can contain undesirable microbes such as,for example, dermally-residing microbes and/or other externalcontaminants.

In some embodiments, the magnitude of the suction force can be modulatedby increasing or decreasing the amount of a force applied to theactuation mechanism 240. For example, in some embodiments, it can bedesirable to limit the amount of suction force introduced to a vein. Insuch embodiments, the user can reduce the amount of force applied to theengagement portion 258 of the second member 251. In this manner, therate of change (e.g., the increase) in the volume of the first reservoir280 can be sufficiently slow to allow time for the negative pressuredifferential between the vein and the fluid reservoir to come toequilibrium before further increasing the volume of the first reservoir280. Thus, the magnitude of the suction force can be modulated.

While in the second configuration, the transfer device 200 can beconfigured to transfer a desired amount (e.g., a predetermined amount)of bodily-fluid transferred to the first reservoir 280. In someembodiments, the first, predetermined amount can substantiallycorrespond to the size of the first reservoir 280. In other embodiments,the first amount can substantially correspond to an equalization ofpressure within the first reservoir 280 and the portion of the patient.Moreover, in such embodiments, the equalization of the pressure can besuch that the valve 270 is allowed to return to the closedconfiguration. Thus, the first reservoir 280 is fluidically isolatedfrom a volume substantially outside the first reservoir 280.

With the first amount fluidically isolated, the actuator mechanism 240can be moved from the second configuration to a third configuration byfurther moving the actuator mechanism 240 in the proximal direction. Forexample, as indicated by the arrow CC in FIG. 6, the user can apply aforce to the engagement portion 258 of the second member 251 to move theactuator mechanism 240 relative to the housing 201. Expanding further,with the protrusion 254 of the second member 251 in contact with theprotrusion 244 of the first member 241, the further application of forceon the engagement portion 258 is such that the first member 241 and thesecond member 251 collectively move in the proximal direction relativeto the housing 201.

The arrangement of the first member 241 within the inner volume 211 ofthe housing 201 is such that the proximal motion of the first member 241increases the volume of the portion of the inner volume 211 that isdistal of the plunger 247, thereby defining the second reservoir 290.Furthermore, with the plunger 247 forming a fluid tight seal with theinner surface of the walls defining the inner volume 211 and with thevalve 270 in the closed configuration, the increase of volume canproduce a negative pressure within the second reservoir 290.

As shown by the arrow DD in FIG. 6, the port 205 and a portion of theinner volume 211 define a fluid flow path that places the secondreservoir 290 in fluid communication with the lumen-defining device.Therefore, the second reservoir 290 is placed in fluid communicationwith the portion of the patient (e.g., the vein). Expanding further, thenegative pressure within the second reservoir 290 produced by themovement of the plunger 247 introduces a suction force within theportion of the patient. Thus, a bodily-fluid is drawn through the port205 and into the second reservoir 290. In addition, the bodily-fluidcontained within the second reservoir 290 is substantially free frommicrobes generally found outside of the portion of the patient (e.g.,dermally residing microbes, microbes within a lumen defined by thetransfer device 200, microbes within the lumen defined by the lumendefining device, and/or any other undesirable microbe).

While not shown in FIGS. 2-6, the actuator mechanism 240 can be movedfrom the third configuration to a fourth configuration to place thetransfer device 200 in a fourth configuration. For example, in someembodiments, with the desired amount of bodily-fluid disposed within thesecond fluid reservoir 290, the transfer device 200 can be removed fromthe portion of the patient and disposed above or in a container (e.g., avile, a test tube, a petri dish, a culture medium, a test apparatus, acartridge designed for use with an automated, rapid microbial detectionsystem, or the like) such that at least a portion of the second amountof bodily-fluid can be tested. The withdrawn bodily-fluid can be usedfor any number of testing processes or procedures such as, for example,blood culture testing, real-time diagnostics, and/or PCR-basedapproaches. Expanding further, the user can apply a force to theengagement portion 258 of the second member 251 to move the actuatormechanism 240 in the distal direction (e.g., opposite the arrow CC shownin FIG. 6). With the valve 270 in the closed configuration thebodily-fluid contained within the first reservoir 280 is maintained influid isolation with a volume outside the first reservoir 280. In someembodiments, the volume of the first reservoir 280 is sufficient tocontain the first centiliter or few centiliters of bodily-fluid. Inother embodiments, the first reservoir 280 can be configured to containfrom about 0.1 ml to about 3.0 ml. In still other embodiments, the firstreservoir 280 can be configured to contain from about 3.0 ml, 4.0 ml,5.0 ml, 6.0 ml, 7.0 ml, 8.0 ml, 9.0 ml, 10.0 ml, 15.0 ml, 20.0 ml, 25.0ml, 50 ml, or any volume or fraction of volume therebetween.Furthermore, the pressure within the first reservoir 280 can be suchthat the force applied to the second member 251 does not substantiallymove the second member 251 relative to the first member 241. Thus, theforce applied to the engagement portion 258 collectively moves thesecond member 251 and the first member 241 in the distal directionrelative to the housing 201 to expel a desired portion of the secondamount of bodily-fluid from the lumen-defining device and into thecontainer.

Although not shown in FIGS. 2-6, in some embodiments, the syringe-basedtransfer device 200 can be coupled to a device in fluid communicationwith the patient that is also configured to reduce contamination of apatient sample. For example, in some embodiments, the syringe-basedtransfer device 200 can be used with a lumenless needle or the like suchas those described in the '758 application.

FIGS. 7-10 illustrate a syringe-based transfer device 300 according toan embodiment. The syringe-based transfer device 300 (also referred toherein as “bodily-fluid transfer device,” “fluid transfer device,” or“transfer device”) is configured to be moved between a first, second,third, and fourth configuration, as further described herein. Thetransfer device 300 includes a housing 301 and an actuator 341.Furthermore, the transfer device 300 is configured to include or definea first fluid reservoir 380 (also referred to herein as “firstreservoir” or “pre-sample reservoir”) and a second fluid reservoir 390(also referred to herein as “second reservoir” or “sample reservoir”).The transfer device 300 can be any suitable shape, size, orconfiguration. For example, while shown in FIGS. 7 and 8 as beingsubstantially cylindrical, the transfer device 300 can be square,rectangular, polygonal, and/or any other non-cylindrical shape.Moreover, portions of the transfer device 300 can be substantiallysimilar to the corresponding portions of the transfer device 200,described above in reference to FIGS. 2-6. Therefore, such portions arenot described in further detail herein and should be consideredsubstantially similar unless explicitly described differently.

As shown in FIGS. 7 and 8, the housing 301 includes a proximal endportion 302 and a distal end portion 303 and defines an inner volume 311therebetween. The proximal end portion 302 of the housing 301 issubstantially open and is configured to receive at least a portion ofthe actuator 341 such that the portion of the actuator 341 is movablydisposed within the inner volume 311. Furthermore, the inner volume 311is configured to define the second fluid reservoir 390, as furtherdescribed herein. The distal end portion 303 of the housing 301 includesa port 305. The port 305 is configured to be coupled to ormonolithically formed with a lumen-containing device, such as thosedescribed above.

As described above, the actuator 341 is disposed within the inner volume311 and is movable between a first position (e.g., a distal positionrelative to the housing 301) and a second position (e.g., a proximalposition relative to the housing 301). The actuator 341 includes aproximal end portion 342 and a distal end portion 343 and defines aninner volume 346 therebetween. The proximal end portion 342 includes anengagement portion 350, as described above with respect to the secondmember 251 of the actuator mechanism 240. In addition, the proximal end342 is substantially open such that at least a portion of the firstreservoir 380 can be movably disposed within the inner volume 346.

The distal end portion 343 of the actuator 341 includes a plunger 347.The plunger 347 is configured to form a friction fit with the innersurface of the walls defining the inner volume 311 when the actuator 341is disposed within the housing 301, as described in detail above inreference FIGS. 2-6. The plunger 347 also defines a channel 348 thatextends though a distal end and a proximal end of the plunger 347. Thechannel 348 is configured to receive a port 375 having a base 376 and apiercing member 377. The base 376 can be disposed within the channel 348and forms a friction fit with a set walls defining the channel 348. Inthis manner, the base 376 and the walls defining the channel 348 canform a substantially fluid tight seal. The piercing member 377 of theport 375 is configured to extend in the proximal direction from the base376. As shown in FIG. 8, the piercing member 377 can be disposed withina sheath configured to be selectively moved to expose, for example, aneedle. For simplicity, FIGS. 8-10 only illustrate a sheath of thepiercing member and not the needle disposed therein.

A portion of the set of walls defining the channel 348 is configured toform a valve seat 349. In this manner, a portion of the channel 348 canreceive a valve 370 such that the valve 370 is in contact with the valveseat 349. The valve 370 can be any suitable configuration, for example,the valve 370 can be similar in form and function to the valve 270described above. In this manner, the arrangement of the plunger 347 andthe valve 370 is such that when the valve 370 is in the openconfiguration, the port 375 is placed in fluid communication with theportion of the inner volume 311 of the housing 301 that is distal of theplunger 347, as further described herein.

In use, a user can engage the transfer device 300 to couple the port 305to a proximal end portion of a lumen-defining device (not shown) suchas, for example, a butterfly needle, a cannula assembly, a trocar (whichin some cases is used to insert a catheter into a patient), or the like.With the port 305 physically coupled to the lumen-defining device, theport 305 is placed in fluid communication with the lumen defined by thelumen-defining device. Furthermore, the distal end portion of thelumen-defining device can be disposed within a portion of the body of apatient (e.g., a vein). In this manner, the port 305 is placed in fluidcommunication with the portion of the body.

With the port 305 coupled to the lumen-defining device, a user (e.g., aphlebotomist, a nurse, a technician, a physician, or the like) can movethe transfer device 300 from the first configuration to the secondconfiguration. In this manner, the user can engage the first reservoir380 and place the first reservoir 380 within the inner volume 346defined by the actuator 341. More specifically, as shown in FIG. 8, thefirst reservoir 380 can be an external fluid reservoir configured toreceive a fluid. For example, in some embodiments, the first reservoir380 can be a Vacutainer® and/or a monolithically formed chamber in thetransfer device 300 with or without a negative pressure. In otherembodiments, the first reservoir 380 can be a pre-sample reservoir suchas those disclosed in the '420 patent. In this manner, the firstreservoir 380 can be placed within the inner volume 346 of the actuator341, as indicated by the arrow EE in FIG. 9.

The insertion of the first reservoir 380 into the inner volume 346 ofthe actuator 341 can place the transfer device 300 in the secondconfiguration. Furthermore, the distal end portion of the firstreservoir 380 can be configured to include a pierceable septum that canreceive the piercing member 377 of the port 375. While not shown in FIG.9, the distal end portion of the first reservoir 380 can engage the port375 such that the sheath of the piercing member 377 is moved, therebyexposing the needle. Thus, the needle can pierce the septum of the firstreservoir 380 to place the first reservoir 380 in fluid communicationwith the port 375. The arrangement of the first reservoir 380 can alsobe such that the inner volume defined therein is substantiallyevacuated. Similarly stated, the inner volume of the first reservoir 380defines a negative pressure.

As shown by the arrow FF in FIG. 9, the port 305, the valve 370, and theport 375 define a fluid flow path such that the first reservoir 380 isin fluid communication with the lumen-defining device. Therefore, thefirst reservoir 380 is placed in fluid communication with the portion ofthe patient (e.g., the vein, the spinal cavity, etc.). Expandingfurther, the negative pressure within the first reservoir 380 can beoperative in moving the valve 370 from a closed configuration to an openconfiguration. In this manner, the negative pressure within the withinthe first reservoir 380 introduces a suction force within the portion ofthe patient. Thus, a bodily-fluid is drawn through the port 305, thevalve 370, and the port 375 and into the first reservoir 380. In someembodiments, the bodily-fluid can contain undesirable microbes such as,for example, dermally-residing microbes and/or other externalcontaminants.

While in the second configuration, the transfer device 300 can beconfigured to transfer a desired amount (e.g., a predetermined amount)of bodily-fluid transferred to the first reservoir 380. In someembodiments, the first, predetermined amount can substantiallycorrespond to an equalization of pressure within the first reservoir 380and the portion of the patient. Moreover, in such embodiments, theequalization the pressure can be such that the valve 370 is allowed toreturn to the closed configuration. Thus, the first reservoir 380 isfluidically isolated from a volume substantially outside the firstreservoir 380.

With the first amount of bodily-fluid (e.g., the amount containingdermally-residing microbes) fluidically isolated, the first reservoir380 can be removed from the inner volume 346 of the actuator 341 anddiscarded. In this manner, the actuator 341 can be moved from the secondconfiguration to a third configuration by moving the actuator 341 in theproximal direction. For example, as indicated by the arrow GG in FIG.10, the user can apply a force to the engagement portion 350 of theactuator 341 to move the actuator 341 relative to the housing 301. Thearrangement of the actuator 341 within the inner volume 311 of thehousing 301 is such that the proximal motion of the actuator 341increases the volume of the portion of the inner volume 311 that isdistal of the plunger 347, thereby defining the second reservoir 390.Furthermore, with the plunger 347 forming a fluid tight seal with theinner surface of the walls defining the inner volume 311 and with thevalve 370 in the closed configuration, the increase of volume canproduce a negative pressure within the second reservoir 390.

As shown by the arrow 1111 in FIG. 10, the port 305 and a portion of theinner volume 311 define a fluid flow path such that the second reservoir390 is in fluid communication with the lumen-defining device. Therefore,the second reservoir 380 is placed in fluid communication with theportion of the patient (e.g., the vein, spinal cavity, etc.). Expandingfurther, the negative pressure within the second reservoir 390 producedby the movement of the plunger 347 introduces a suction force within theportion of the patient. Thus, a bodily-fluid is drawn through the port305 and into the second reservoir 390. In addition, the bodily-fluidcontained within the second reservoir 390 is substantially free frommicrobes generally found outside of the portion of the patient (e.g.,dermally residing microbes, microbes within a lumen defined by thetransfer device 300, microbes within the lumen defined by the lumendefining device, and/or any other undesirable microbe). Although notshown in FIGS. 7-10, in some embodiments, the syringe-based transferdevice 300 can be coupled to a device in fluid communication with thepatient that is also configured to reduce contamination of a patientsample. For example, in some embodiments, the syringe-based transferdevice 300 can be used with a lumenless needle or the like such as thosedescribed in the '758 application.

While not shown in FIGS. 7-10, the actuator 341 can be moved from thethird configuration to a fourth configuration to place the transferdevice 300 in a fourth configuration. For example, in some embodiments,with the desired amount of bodily-fluid disposed within the second fluidreservoir 390, the transfer device 300 can be removed from the portionof the patient and disposed above or in a container (e.g., a vile, atest tube, a petri dish, a culture medium, a test apparatus, a cartridgeor the like) such that a portion of the second amount of bodily-fluidcan be tested. Expanding further, the user can apply a force to theengagement portion 350 to move the actuator 341 in the distal direction.Therefore, with the valve 370 in the closed configuration the forceapplied to the engagement portion 350 the actuator 341 in the distaldirection relative to the housing 301 to expel a desired portion of thesecond amount of bodily-fluid from the lumen-defining device and intothe container.

While the embodiments shown above describe an actuator being operativein directing a flow of a bodily-fluid, in some embodiments, a transferdevice can include a flow control mechanism configured to direct a flowof the bodily-fluid. For example, FIGS. 11-15 illustrate a syringe-basedtransfer device 400 according to an embodiment. The syringe-basedtransfer device 400 (also referred to herein as “bodily-fluid transferdevice,” “fluid transfer device,” or “transfer device”) includes ahousing 401, a flow control mechanism 430, and an actuator mechanism440. Furthermore, the transfer device 400 is configured to include ordefine a first fluid reservoir 480 (also referred to herein as “firstreservoir” or “pre-sample reservoir”) and a second fluid reservoir 490(also referred to herein as “second reservoir” or “sample reservoir”).The transfer device 400 can be any suitable shape, size, orconfiguration. For example, while shown in FIGS. 11 and 12 as beingsubstantially cylindrical, the transfer device 400 can be square,rectangular, polygonal, and/or any other non-cylindrical shape.Moreover, portions of the transfer device 400 can be substantiallysimilar to the corresponding portions of the transfer device 200,described above in reference to FIGS. 2-6. Therefore, such portions arenot described in further detail herein and should be consideredsubstantially similar unless explicitly described differently.

As shown in FIGS. 11 and 12, the housing 401 includes a proximal endportion 402, a distal end portion 403, and defines an inner volume 411therebetween. The proximal end portion 402 of the housing 401 issubstantially open and is configured to receive at least a portion ofthe actuator mechanism 440 such that the portion of the actuatormechanism 440 is movably disposed within the inner volume 411.Furthermore, the inner volume 411 is configured to define, at leastpartially, the first fluid reservoir 480 the second fluid reservoir 490,as further described herein.

The distal end portion 403 of the housing 401 includes a port 405 and adiverter 409. The port 405 is configured to be coupled to ormonolithically formed with a lumen-containing device, such as thosedescribed above. The diverter 409 defines a void 408 that movablyreceives a portion of the flow control mechanism 430. As shown in FIG.13, the void 408 is in fluid communication with the port 405. Thediverter 409 further defines a first lumen 406 in fluid communicationwith the void 408 and a first portion of the inner volume 411, and asecond lumen 407 in fluid communication with the void 408 and a secondportion of the inner volume 411. In this manner, the diverter 409 canselectively receive a flow of a bodily-fluid as further describedherein.

Referring back to FIG. 12, the flow control mechanism 430 includes afirst member 431 and a second member 435. As described above, at least aportion of the flow control mechanism 430 is movably disposed within aportion of the housing 401. More specifically the first member 431 isrotatably disposed within the void 408 of the diverter 409. The firstmember 431 defines a first lumen 432 and a second lumen 433 and definesa circular cross-sectional shape. In this manner, the first member 431can be disposed within the void 408 such that a portion of the firstmember 431 forms a friction fit with the walls of the diverter 409defining the void 408. For example, in some embodiments, the firstmember 431 is formed from silicone and has a diameter larger than thediameter of the void 408. In this manner, the diameter of the firstmember 431 is reduced when the first member 431 is disposed within thevoid 408. Thus, the outer surface of the first member 431 forms afriction fit with the inner surface of the walls defining the void 408.In other embodiments, the first member 431 can be any suitable elastomerconfigured to deform when disposed within the void 408 of the diverter409.

The second member 435 is disposed substantially outside the void 408 andcan be engaged by a user to rotate the flow control mechanism 430between a first configuration and a second configuration. In addition,the first member 431 can be coupled to and/or otherwise engage thesecond member 445. For example, in some embodiments, the second member435 can be coupled to the first member 431 via a mechanical fastenerand/or adhesive. In other embodiments, the second member 435 and thefirst member 431 can be coupled in any suitable manner. Therefore, thefirst member 431 is configured to move concurrently with the secondmember 435 when the second member 435 is rotated relative to the housing401. In this manner, the flow control mechanism 430 can be rotated toplace the first lumen 432 or the second lumen 433 in fluid communicationwith the port 405, the first lumen 406, and/or the second lumen 407, asdescribed in further detail herein.

As described above, the actuator mechanism 440 is disposed within theinner volume 411 and is movable between a first position (e.g., a distalposition relative to the housing 401) and a second position (e.g., aproximal position relative to the housing 401). Furthermore, themovement of the actuator mechanism 440 relative to the housing 401 canmove the transfer device 400 between a first, second, and thirdconfiguration, as further described herein. The actuator mechanism 440includes a first member 470 and a second member 451. The first member470 includes a shunt tube 471 and a plunger 476. The plunger 476 definesa channel 477 is configured to be movably disposed about the shunt tube471. Similarly stated, the shunt tube 471 is disposed within the channel477. The plunger 476 can be substantially similar in function to thosedescribed in detail above. For example, the plunger 476 can beconfigured to form a friction fit with a set of walls that define theinner volume 411 of the housing 401. In this manner, the plunger 476 andthe walls defining the inner volume 411 form a substantially fluid tightseal. Similarly, the plunger 476 and the shunt tube 471 form asubstantially fluid tight seal. Therefore, the plunger 476 fluidicallyisolates a portion of the inner volume 411 proximal of the plunger 476from a portion of the inner volume 411 distal of the plunger 476.

The shunt tube 471 includes a proximal end portion 472 and a distal endportion 473. The distal end portion 473 is coupled to a portion of thediverter 409 such that a lumen 475 defined by the shunt tube 471 is influid communication with the second lumen 407 defined by the diverter409. The proximal end portion 472 of the shunt tube 471 includes aprotrusion 474 that is configured to engage the plunger 476 tosubstantially limit a proximal movement of the plunger 476 relative tothe shunt tube 471, as further described herein.

The second member 451 of the actuator mechanism 440 includes a proximalend portion 452 and a distal end portion 453. The proximal end portion452 includes an engagement portion 458 that can be engaged by a user(e.g., a phlebotomist, a nurse, a technician, a physician, etc.) to moveat least a portion of the actuator mechanism 440 relative to the housing401. The distal end portion 453 includes a plunger 457 configured toform a friction fit with the inner surface of the walls defining theinner volume 446 when the second member 451 is disposed with the innervolume 411. Similarly stated, the plunger 457 defines a fluidic sealwith the inner surface of the walls defining the inner volume 411 suchthat a portion of the inner volume 411 proximal of the plunger 457 isfluidically isolated from a portion of the inner volume 411 distal ofthe plunger 457.

While not shown in FIGS. 11-15, the second member 451 can be at leasttemporarily coupled to the plunger 476 of the first member 470. Forexample, in some embodiments, the plunger 457 of the second member 451can include a protrusion configured to be disposed within a groovedefined by the plunger 476 of the first member 470. In this manner, thefirst member 470 and the second member 451 can be configured tocollectively move, at least temporarily, within the housing 401, and canfurther be configured to move, at least temporarily, relative to eachother.

As shown in FIG. 13, the distal end portion 453 defines a channel 459configured to be selectively disposed about a portion of the shunt tube471. Expanding further, the channel 459 can be configured to have adiameter that is sufficiently large such that the second member 451 canfreely move about the shunt tube 471 (e.g., the shunt tube 471 and thewalls defining the channel do not form a substantial friction fit.

In use, a user can engage the transfer device 400 to couple the port 405to a proximal end portion of a lumen-defining device (not shown) suchas, for example, a butterfly needle, a cannula assembly, a trocar (whichin some cases is used to insert a catheter into a patient), or the like.With the port 405 physically coupled to the lumen-defining device, theport 405 is placed in fluid communication with the lumen defined by thelumen-defining device. Furthermore, the distal end portion of thelumen-defining device can be disposed within a portion of the body of apatient (e.g., a vein, spinal column, etc.). In this manner, the port405 is placed in fluid communication with the portion of the body.

With the port 405 coupled to the lumen-defining device, a user (e.g., aphlebotomist, a nurse, a technician, a physician, or the like) can movethe transfer device 400 from the first configuration to the secondconfiguration. More specifically, the user can engage the engagementportion 458 of the second member 451 included in the actuator mechanism440 to move the actuator mechanism 440 from its first configuration toits second configuration, thereby placing the transfer device 400 in thesecond configuration, as indicated by the arrow II in FIG. 14. In thismanner, the actuator mechanism 440 is moved in a proximal directionrelative to the housing 401

The arrangement of the actuator mechanism 440 is such that the proximalmotion of the second member 451 moves the plunger 476 of the firstmember 470 in the proximal direction relative to the shunt tube 471.Expanding further, the first member 470 can be at least temporarilycoupled to the second member 451 such that the first member 470 and thesecond member 451 move concurrently in the proximal direction relativeto the housing 401. In this manner, the first member 470 moves in theproximal direction until the first member 470 is placed in contact withthe protrusion 474 included in the shunt tube 471. Moreover, theproximal movement of the plunger 476 increases the volume of the portionof the inner volume 411 of the housing 401 that is distal of the plunger476, thereby defining the first reservoir 480, as shown in FIG. 14. Withthe plunger 476 forming a fluid tight seal with the inner surface of thewalls defining the inner volume 411 and with the shunt tube 471 aboutwhich the plunger 476 is disposed, the volume increase of the portion ofthe inner volume 411 can produce a negative pressure within the firstreservoir 480.

While the transfer device 400 is placed in the second configuration, theflow control mechanism 430 can be maintained in the first configuration.In this manner, first member 431 of the flow control mechanism 430 canbe disposed within the void 408 such that the first lumen 432 defined bythe flow control mechanism 430 is in fluid communication with the port405 and in fluid communication with the first lumen 406 defined by thediverter 409. In this manner, the port 405, the first lumen 432 definedby the flow control mechanism 430, and the first lumen 406 defined bythe diverter 409 define a fluid flow path that places the firstreservoir 480 in fluid communication with the lumen-defining device, asindicated by the arrow JJ in FIG. 14. Therefore, the first reservoir 480is placed in fluid communication with the portion of the patient (e.g.,the vein). Expanding further, the negative pressure within the firstreservoir 480 produced by the movement of the plunger 476 (as indicatedby the arrow II) introduces a suction force within the portion of thepatient. Thus, a bodily-fluid is drawn through the port 405, the firstlumen 432 defined by the flow control mechanism 430, and the first lumen406 defined by the diverter 409 and into the fluid reservoir 480. Insome embodiments, the bodily-fluid can contain undesirable microbes suchas, for example, dermally-residing microbes and/or other externalcontaminants.

In some embodiments, the magnitude of the suction force can be modulatedby moving the rotating the flow control mechanism 430 relative to thediverter 409. The rotation of the flow control mechanism 330 reduces thesize of the fluid pathway (e.g., an inner diameter) between the port 405and the first lumen 432 of the flow control mechanism 430 and the firstlumen 406 of the diverter 409 and the first lumen 432 of the flowcontrol mechanism 430, thereby reducing the suction force introducedinto the vein of the patient.

With the desired amount of bodily-fluid transferred to the firstreservoir 480, a user can engage the transfer device 400 to move thetransfer device 400 from the second configuration to the thirdconfiguration. In some embodiments, the desired amount of bodily-fluidtransferred to the first reservoir 480 is a predetermined amount offluid (as described above). In some embodiments, the volume of the firstreservoir 480 is sufficient to contain the first centiliter or fewcentiliters of bodily-fluid. In other embodiments, the first reservoir480 can be configured to contain from about 0.1 ml to about 3.0 ml. Instill other embodiments, the first reservoir 480 can be configured tocontain from about 3.0 ml, 4.0 ml, 5.0 ml, 6.0 ml, 7.0 ml, 8.0 ml, 9.0ml, 10.0 ml, 15.0 ml, 20.0 ml, 25.0 ml, 50 ml, or any volume or fractionof volume therebetween. In some embodiments, the predetermined amount ofbodily-fluid (e.g., volume) is at least equal to the combined volume ofthe port 405, the first lumen 432 of the flow control mechanism 430, thefirst lumen 406 of the diverter 409, and the lumen-defining device. Inother embodiments, the flow control mechanism 430 can be configured toautomatically move from the first configuration to the secondconfiguration to divert fluid flow without user intervention.

As shown in FIG. 15, the transfer device 400 can be moved from thesecond configuration to the third configuration by rotating the secondmember 435 of the flow control mechanism 430 relative to the diverter409, as indicated by the arrow KK. In this manner, the flow controlmechanism 430 is moved to the second configuration, and the first lumen432 is fluidically isolated from the port 405 and the first lumen 406 ofthe diverter 409. Thus, the first reservoir 480 is fluidically isolatedfrom a volume substantially outside the first reservoir 480. Inaddition, the second lumen 433 defined by the flow control mechanism 430is placed in fluid communication with the port 405 and the second lumen407 defined by the diverter 409. Therefore, the port 405, the secondlumen 433 of the flow control mechanism 430, the second lumen 407 of thediverter 409, and the lumen 475 of the shunt tube 471 define a fluidflow path, as indicated by the arrow LL.

With the flow control mechanism 430 placed in the second configuration,the second member 451 of the actuator mechanism 440 can be moved fromthe second configuration to a third configuration. Expanding further,with the plunger 476 in contact with the protrusion 474 of the shunt471, the second member 451 can be moved in the proximal direction todecouple the second member 451 from the plunger 476 (as described abovethe plunger 476 is at least temporarily coupled to the first member451). In this manner, the second member 451 can be moved in the proximaldirection relative to the first member 470, as indicated by the arrow MMin FIG. 15. The proximal movement of the second member 451 relative tothe first member 470 increases the volume of the portion of the innervolume 411 that is proximal of the plunger 476 of the first member 470and distal of the plunger 457 of the second member 451, thereby definingthe second reservoir 490.

With the plunger 476 of the first member 470 and the plunger 457 of thesecond member 451 forming a fluid tight seal with the inner surface ofthe walls defining the inner volume 411, the volume increase of theportion of the inner volume 411 can produce a negative pressure withinthe first reservoir 490. Thus, the negative pressure within the secondreservoir 490 is such that the negative pressure differential betweenthe second reservoir 490 and the portion of the body of the patientintroduces a suction force within the portion of the patient. Therefore,a desired amount of bodily-fluid is drawn through the port 405, thesecond lumen 433 of the flow control mechanism 430, the second lumen 407of the diverter 409, and the lumen 475 defined by the shunt tube 471 andinto the second reservoir 490. Moreover, the bodily-fluid disposedwithin the second reservoir 490 is fluidically isolated from the first,predetermined amount of bodily-fluid contained within the firstreservoir 480.

Although not shown in FIGS. 11-15, in some embodiments, thesyringe-based transfer device 400 can be coupled to a device in fluidcommunication with the patient that is also configured to reducecontamination of a patient sample. For example, in some embodiments, thesyringe-based transfer device 400 can be used with a lumenless needle orthe like such as those described in the '758 application.

While not shown in FIGS. 11-15, the actuator mechanism 440 can be movedfrom the third configuration to a fourth configuration to place thetransfer device 400 in a fourth configuration. For example, in someembodiments, with the desired amount of bodily-fluid disposed within thesecond fluid reservoir 490, the transfer device 400 can be removed fromthe portion of the patient and disposed above or in a container (e.g., avile, a test tube, a petri dish, a culture medium, a test apparatus, orthe like) such that a portion of the second amount of bodily-fluid canbe tested. Expanding further, the user can apply a force to theengagement portion 458 to move the second member 451 in the distaldirection. Therefore, the force applied to the engagement portion 458moves the second member 451 in the distal direction relative to thehousing 301 to expel a desired portion of the second amount ofbodily-fluid from the lumen-defining device and into the container.

FIG. 16 is a flowchart illustrating a method 1000 of using asyringe-based transfer device to obtain a bodily fluid sample from apatient. The syringe-based transfer device can be any suitable devicesuch as those described herein. Accordingly, the syringe-based transferdevice can include a housing having a port configured to be coupled tothe patient, and an actuator mechanism movably disposed in the housing.For example, the housing, the port, and the actuator mechanism can besubstantially similar to or the same as the housing 201, the port 205,and the actuator mechanism 240, respectively, described above withreference to FIGS. 2-6.

The method 1000 includes establishing fluid communication between thepatient and the port of the syringe-based transfer device, at 1001. Forexample, the port can be coupled to a proximal end portion of alumen-defining device such as, for example, a butterfly needle, acannula assembly, or the like that is in fluid communication with thepatient (e.g., at least a distal end portion of the lumen-definingdevice is disposed in the body of the patient). With the port physicallyand fluidically coupled to the lumen-defining device, the port is placedin fluid communication with the body.

With the port coupled to the lumen-defining device, a user can establishfluid communication between the port and a pre-sample reservoir includedin and/or defined by the syringe-based transfer device, at 1002. Forexample, the user can move the actuator mechanism from a firstconfiguration to a second configuration, thereby placing the port influid communication with the pre-sample reservoir. In some embodiments,the movement of the actuator mechanism can increase an inner volumewhich, in turn, can produce a negative pressure within the pre-samplereservoir, as described above with reference to the transfer device 200in FIG. 5. As described above, in some embodiments, the syringe-basedtransfer device can be manipulated to modulate the magnitude of suctionforce by controlling the movement of the actuator mechanism. In thismanner, a first volume of bodily-fluid is transferred to the pre-samplereservoir with the syringe-based transfer device, at 1003. In someembodiments, the bodily-fluid can contain undesirable microbes such as,for example, dermally-residing microbes and/or other externalcontaminants.

The first volume of bodily-fluid can be any suitable volume. Forexample, in some embodiments, the first volume of bodily-fluidtransferred to the pre-sample reservoir can be a predetermined volume.In some embodiments, the first volume can be, for example, about 0.1 ml,about 0.3 ml, about 0.5 ml, about 1.0 ml, about 2.0 ml, about 3.0 ml,about 4.0 ml, about 5.0 ml, about 10.0 ml, about 20 ml, about 50 ml,and/or any volume or fraction of a volume therebetween. In otherembodiments, the first volume can be greater than 50 ml or less than 0.1ml. In some embodiments, the first volume can substantially correspondto the size of the pre-sample reservoir 280. Once the first volume ofbodily-fluid is transferred to the pre-sample, reservoir, the pre-samplereservoir is fluidically isolated from the port to sequester the firstvolume of bodily-fluid in the pre-sample reservoir, at 1004. Forexample, in some embodiments, the user can move the actuator mechanismand/or otherwise manipulate the syringe-based transfer device tofluidically isolate the pre-sample reservoir.

With the first amount fluidically isolated, fluid communication isestablished between the port and a sample reservoir defined at least inpart by the actuator mechanism and the housing of the syringe-basedtransfer device, at 1005. For example, in some embodiments, the housingcan define an inner volume in which the actuator mechanism is at leastpartially disposed. In some embodiments, the actuator mechanism caninclude a seal member or plunger that can form a substantially fluidtight seal with a set of walls defining the inner volume of the housing,thereby defining the sample reservoir. For example, the actuatormechanism and the housing can define the sample reservoir in a similarmanner as described above with reference to the actuator mechanism 240,the housing 201, and the sample reservoir 290 of FIG. 6. As such, theactuator mechanism can be moved from a first position to a secondposition to draw a second volume of bodily-fluid from the patient intothe sample reservoir, at 1006. With the first volume of bodily-fluidsequestered in the pre-sample reservoir, the second volume ofbodily-fluid transferred to the sample reservoir can be substantiallyfree from contaminants such as, for example, dermally residing microbesor the like.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods and steps described above indicate certainevents occurring in certain order, those of ordinary skill in the arthaving the benefit of this disclosure would recognize that the orderingof certain steps may be modified and that such modifications are inaccordance with the variations of the invention. Additionally, certainsteps may be performed concurrently in a parallel process when possible,as well as performed sequentially as described above. Additionally,certain steps may be partially completed before proceeding to subsequentsteps. For example, while the flow control mechanism 430 of the transferdevice 400 is described above (with reference to FIG. 15) as being movedprior to the second member 451 of the actuator mechanism 440, in someembodiments, the second member 451 can be moved prior to or concurrentlywith the flow control mechanism 430.

While various embodiments have been particularly shown and described,various changes in form and details may be made. For example, while theflow control mechanism 430 is shown and described with respect to FIGS.11-15 as being rotated in a single direction, in other embodiments, aflow control mechanism can be rotated in a first direction (e.g., in thedirection of the arrow KK in FIG. 15) and a second direction, oppositethe first. In such embodiments, the rotation in the second direction canbe configured to move a transfer device through any number ofconfigurations. In other embodiments, the rotation of the flow controlmechanism in the second direction can be limited. For example, in someembodiments, the flow control mechanism can be limitedly rotated in thesecond direction to reduce the diameter of a flow path between the flowcontrol mechanism and a lumen such as to reduce a suction force, asdescribed above.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having any combination or sub-combination of any featuresand/or components from any of the embodiments described herein. Forexample, while the transfer device 400 is shown in FIGS. 11-15 as notincluding a valve (e.g., such as those described in the transfer devices200 and 300), in some embodiments, the transfer device 400 can include avalve. For instance, the transfer device 400 can include a valve in thefirst lumen 406 of the diverter 409, or at any other suitable position.

The specific configurations of the various components can also bevaried. For example, the size and specific shape of the variouscomponents can be different than the embodiments shown, while stillproviding the functions as described herein. More specifically, the sizeand shape of the various components can be specifically selected for adesired rate of bodily-fluid flow into a fluid reservoir.

1.-34. (canceled)
 35. A bodily-fluid transfer device for obtainingbodily fluid from a patient, comprising: a housing defining at least aportion of a first inner volume, the housing including a port; anactuator at least partially disposed in the first inner volume of thehousing, the actuator including a distal end portion and a proximal endportion and defining a second inner volume therebetween, the distal endportion having a sealing member, the proximal end portion beingsubstantially open, the actuator configured to move from a firstconfiguration to a second configuration in response to a force beingapplied to the actuator to increase a portion of the first inner volumedisposed distal to the sealing member such that a first volume of bodilyfluid can be received from the patient into the portion of the firstinner volume; a channel extending proximally from the sealing member,the channel configured to provide fluid communication between the portand a container disposed proximal to the sealing member and at leastpartially within the second inner volume; and a valve disposed in theactuator, the valve configured to open in response to a difference inpressure between a valve inlet and a valve outlet to allow a secondvolume of bodily fluid to be received from the patient into thecontainer.
 36. The bodily-fluid transfer device of claim 35, furthercomprising a piercing member configured to pierce the container when thecontainer is at least partially disposed within the second inner volumeenabling a negative pressure to be applied to the channel to open thevalve.
 37. The bodily-fluid transfer device of claim 36, furthercomprising a sheath configured to be selectively moved to expose thepiercing member.
 38. The bodily-fluid transfer device of claim 35,wherein the actuator is configured to move from the second configurationto the first configuration in response to an opposite force beingapplied to the actuator to dispense at least a portion of the firstvolume of bodily fluid from the first inner volume.
 39. The bodily-fluidtransfer device of claim 35, wherein the valve is further configured toclose in response to an equalization in pressure between the valve inletand the valve outlet.
 40. The bodily-fluid transfer device of claim 35,wherein the valve is disposed in the channel.
 41. The bodily-fluidtransfer device of claim 35, wherein the valve is a one-way check valve.42. The bodily-fluid transfer device of claim 35, wherein the actuatorin the second configuration is configured to generate negative pressurewithin the portion of the first inner volume disposed distal to thesealing member to draw the first volume of bodily fluid into the portionof the first inner volume.
 43. The bodily-fluid transfer device of claim35, wherein the actuator includes a protrusion configured to selectivelyengage with a portion of the housing to limit movement of the actuatorrelative to the housing.
 44. The bodily-fluid transfer device of claim35, wherein the housing is a syringe housing that includes a cylindricalbody.
 45. The bodily-fluid transfer device of claim 35, wherein thesealing member is a plunger.
 46. The bodily-fluid transfer device ofclaim 35, wherein the channel is configured to extend proximally fromthe port when the actuator is in the first configuration.
 47. Abodily-fluid transfer device for obtaining bodily fluid from a patient,comprising: a syringe housing having a cylindrical body and a port; anactuator at least partially disposed in the cylindrical body, theactuator defining an inner volume and having a proximal end with anopening that opens into the inner volume, the actuator further includinga plunger at a distal end that is configured to form a fluid tight sealwith an inner surface of the cylindrical body, the actuator configuredto be moved proximally relative to the cylindrical body to increase avolume of a reservoir defined by the cylindrical housing between theport and the plunger to draw a first volume of bodily fluid from thepatient into the area; a channel extending proximally from the plungerand into the inner volume defined by the actuator, the channel definingat least part of a fluid flow path between the patient and a containerconfigured to be at least partially received within the actuator; and avalve disposed in the actuator, the valve configured to open in responseto a difference in pressure between a valve inlet and a valve outlet toallow a second volume of bodily fluid to be received from the patientvia the fluid flow path into the container.
 48. The bodily-fluidtransfer device of claim 47, wherein the port is a Luer lock port. 49.The bodily-fluid transfer device of claim 47, further comprising apiercing member configured to pierce the container when the container isat least partially received within the actuator enabling a vacuum to beapplied to the channel to open the valve.
 50. The bodily-fluid transferdevice of claim 49, further comprising a sheath configured to beselectively moved to expose the piercing member.
 51. The bodily-fluidtransfer device of claim 47, wherein the valve is further configured toclose in response to an equalization in pressure between the valve inletand the valve outlet.
 52. The bodily-fluid transfer device of claim 47,wherein the valve is disposed in the channel.
 53. The bodily-fluidtransfer device of claim 47, wherein the actuator when moved proximallyrelative to the cylindrical body is configured to generate negativepressure within the reservoir to draw the first volume of bodily fluidinto the reservoir.
 54. The bodily-fluid transfer device of claim 47,wherein the actuator includes a protrusion configured to selectivelyengage with a portion of the syringe housing to limit movement of theactuator relative to the syringe housing.
 55. The bodily-fluid transferdevice of claim 47, wherein the port at least partially defines anotherfluid flow path that is separate from the channel and configured toreceive the first volume of bodily fluid from the patient.